England’s health service will use drones to deliver vital chemotherapy drugs

The UK’s National Health Service has announced that it will test delivering vital chemotherapy drugs via drone to the Isle of Wight. The body has partnered with Apian, a drone technology startup founded by former NHS doctors and former Google employees. Test flights are due to begin shortly, and it’s hoped that the system will reduce journey times for the drugs, cut costs and enable cancer patients to receive treatment far more locally.

The Isle of Wight is an island two miles off the south coast of England with a population just under 150,000. Due to the short shelf-life of most chemotherapy drugs, medicines are either rushed onto the island or patients take the ferry to the mainland. This journey can take up to four hours, while a drone flight can run from Queen Alexandra Hospital to St. Mary’s Hospital in half an hour. Not long after and an additional pilot scheme will take place in Northumbria to see if it’s possible to deliver vital medical supplies at ultra-short notice.

It’s not the first time that drones have been used to deliver vital medicines faster than a conventional courier. Merck and drone company Volansi began testing the delivery of cold-chain medicines to patients in rural North Carolina. Similarly, drone technology has helped move blood supplies across Rwanda, deliver prescriptions to senior citizens in Florida and help with supply drops during COVID-19.

Similarly, the UK’s Royal Mail has tested using autonomous delivery drones to get packages to remote areas. That includes getting vital supplies to the islands of Scilly, Shetland, Orkney and the Hebrides. Much like the NHS trial, Royal Mail said that using drones would reduce carbon emissions and speed up delivery times, especially in far-flung regions where infrastructure costs are too excessive to even think about.

FDA asks COVID-19 vaccine makers to update boosters to target new Omicron variants

The Food and Drug Administration has asked COVID-19 vaccine makers to update booster shots to tackle newer Omicron variants that are on the rise. It says the manufacturers should add a spike protein component to shots to target the Omicron BA.4 and BA.5 variants in addition to the original strain.

An "overwhelming majority" of the FDA's advisory committee voted this week in favor of updating shots with an Omicron component, in the hopes of starting to use those modified boosters in the fall. The advisory is only for booster shots and not primary inoculations.

Vaccine makers are essentially playing whack-a-mole with the various strains of COVID-19. Pfizer and Moderna have created versions of their vaccines that target BA.1, the Omicron variant that caused a significant upswing in COVID-19 cases during the winter.

However, that strain isn't circulating in the US anymore, according to the Centers for Disease Control and Prevention. Earlier this week, the CDC said BA.4 and BA.5 now account for over 52 percent of COVID-19 infections in the US. That figure is expected to rise in the coming weeks.

As CNBC notes, Pfizer and Moderna released clinical trial data this week showing that the current Omicron shots performed better against BA.1 than the original versions of their vaccines in terms of offering a stronger immune response. While the immune response against BA.4 and BA.5 was still said to be robust, the Omicron inoculations were less effective against those strains. It's unclear how long it will take vaccine makers to develop shots that take aim at BA.4 and BA.5.

"Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an Omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an Omicron BA.4/5 component," the FDA said. "Manufacturers will also be asked to begin clinical trials with modified vaccines containing an Omicron BA.4/5 component, as these data will be of use as the pandemic further evolves."

FDA asks COVID-19 vaccine makers to update boosters to target new Omicron variants

The Food and Drug Administration has asked COVID-19 vaccine makers to update booster shots to tackle newer Omicron variants that are on the rise. It says the manufacturers should add a spike protein component to shots to target the Omicron BA.4 and BA.5 variants in addition to the original strain.

An "overwhelming majority" of the FDA's advisory committee voted this week in favor of updating shots with an Omicron component, in the hopes of starting to use those modified boosters in the fall. The advisory is only for booster shots and not primary inoculations.

Vaccine makers are essentially playing whack-a-mole with the various strains of COVID-19. Pfizer and Moderna have created versions of their vaccines that target BA.1, the Omicron variant that caused a significant upswing in COVID-19 cases during the winter.

However, that strain isn't circulating in the US anymore, according to the Centers for Disease Control and Prevention. Earlier this week, the CDC said BA.4 and BA.5 now account for over 52 percent of COVID-19 infections in the US. That figure is expected to rise in the coming weeks.

As CNBC notes, Pfizer and Moderna released clinical trial data this week showing that the current Omicron shots performed better against BA.1 than the original versions of their vaccines in terms of offering a stronger immune response. While the immune response against BA.4 and BA.5 was still said to be robust, the Omicron inoculations were less effective against those strains. It's unclear how long it will take vaccine makers to develop shots that take aim at BA.4 and BA.5.

"Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an Omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an Omicron BA.4/5 component," the FDA said. "Manufacturers will also be asked to begin clinical trials with modified vaccines containing an Omicron BA.4/5 component, as these data will be of use as the pandemic further evolves."

FDA bans sales of Juul vape products in the US

The Food and Drug Administration has banned e-cigarette maker Juul from selling and distributing its products in the US. It ordered the company to remove its wares from the market or face enforcement actions. 

Reports earlier this week suggested that an FDA ban on Juul products was imminent. After a two-year review, the agency rejected Juul's application to keep selling tobacco- and menthol-flavored pods, as well as its vape pen. Juul told Engadget that it intends to seek a stay on the decision. It is exploring all other options, including an appeal.

The ban doesn't apply to Juul products that are already in the possession of the company's customers. However, it'll be difficult, if not impossible, to find its pens and pods in the near future.

In 2020, the FDA began a comprehensive review of all e-cigarette products sold in the US. It weighed up the potential benefits of vaping compared with cigarettes for adult smokers against the popularity of e-cigarettes among underage users. The agency has permitted other manufacturers to continue selling vape products, including NJOY and Vuse parent Reynolds American. To date, the agency has authorized 23 "electronic nicotine delivery systems" (to give vape pens their formal name).

In Juul's case, though, the FDA said the company's application "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications."

The agency went on to say that it doesn't have clinical information that suggests there is "an immediate hazard" linked to Juul's pen or pods. "However, the [marketing denial orders] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products," the FDA said. It noted that it's not possible to grasp the possible harms of using other pods in a Juul vape pen or the company's pods in third-party devices.

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

The company became the leader in the US e-cigarette market in 2018. However, sales have dropped following a string of controversies. Juul slipped to second place behind Vuse in terms of US market share. The vast majority of the company's revenue comes from the US, The Wall Street Journal noted this week. 

Juul had been accused by federal agencies, state attorneys general and other officials of marketing its products to teens. The company agreed to pay eight-figure settlements related to lawsuits in North Carolina and Washington state, and it has faced suits in several other states. 

The company halted sales of mint- and fruit-flavored vape pods in 2019 before the FDA banned most flavored variants in early 2020. According to the Centers for Disease Control and Prevention, nearly 85 percent of young people who tried e-cigarettes said they used flavored varieties. However, vaping has become less popular among teens overall, according to data from 2021. In 2019, Juul revealed a new, connected version of its vape pen that can verify a user's identity in an attempt to prevent underage use. 

Update 6/23 12:50PM ET: Juul Labs' chief regulatory officer Joe Murillo provided Engadget with the following statement:

We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency.
In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being appropriate for the protection of the public health.
We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator. We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.

FDA clears Rune Labs to use the Apple Watch to monitor Parkinson’s

Turns out the Apple Watch’s motion sensors can be a useful tool for Parkinson’s patients and their physicians. The FDA has granted approval to Rune Labs to use their software paired with the Apple Watch to track symptoms of Parkinson’s disease, Reutersreported today. The San Francisco-based digital health startup has created software for watchOS that can detect common Parkinson’s symptoms such as tremors, involuntary or slow movement, rigidity and poor balance. Smartphone and other remote forms of monitoring Parkinson’s have been around for a while, but this is the first software designed for the Apple Watch that the FDA has cleared for motion disorders.

Since the Apple Watch Series 4 was first released in 2018, the wearable has been able to detect hard falls and offer advanced activity metrics. The company that same year added a Movement Disorder API to its open-source ResearchKit, opening the door for developers to create watchOS apps to track Parkinson’s and other diseases. As Rune Lab notes, the company is the first to make use of the API for commercial purposes.

The watchOS app by Rune Labs will give physicians access to patient movement data over time, which can further supplement the information they get from an in-person physical exam. Rune Labs also notes the Apple Watch’s tools aren’t capable of giving patients a complete picture of their disorder. “Of course, there are limitations to Apple's Movement Disorder kit: tremor and dyskinesia are only two symptoms in Parkinson’s Disease, and the classifiers themselves are not yet perfect,” wrote Rune Labs founder Brian Pepin last year in a blog post.

Apple has focused a lot of time and money on expanding and updating the Watch's health and fitness tracking capabilities, with many more to come in future updates. Earlier this month the FDA also cleared watchOS's AFib History feature — which monitors irregular and extremely rapid heartbeat — and will be released in the upcoming watchOS 9 update. 

FDA clears Rune Labs to use the Apple Watch to monitor Parkinson’s

Turns out the Apple Watch’s motion sensors can be a useful tool for Parkinson’s patients and their physicians. The FDA has granted approval to Rune Labs to use their software paired with the Apple Watch to track symptoms of Parkinson’s disease, Reutersreported today. The San Francisco-based digital health startup has created software for watchOS that can detect common Parkinson’s symptoms such as tremors, involuntary or slow movement, rigidity and poor balance. Smartphone and other remote forms of monitoring Parkinson’s have been around for a while, but this is the first software designed for the Apple Watch that the FDA has cleared for motion disorders.

Since the Apple Watch Series 4 was first released in 2018, the wearable has been able to detect hard falls and offer advanced activity metrics. The company that same year added a Movement Disorder API to its open-source ResearchKit, opening the door for developers to create watchOS apps to track Parkinson’s and other diseases. As Rune Lab notes, the company is the first to make use of the API for commercial purposes.

The watchOS app by Rune Labs will give physicians access to patient movement data over time, which can further supplement the information they get from an in-person physical exam. Rune Labs also notes the Apple Watch’s tools aren’t capable of giving patients a complete picture of their disorder. “Of course, there are limitations to Apple's Movement Disorder kit: tremor and dyskinesia are only two symptoms in Parkinson’s Disease, and the classifiers themselves are not yet perfect,” wrote Rune Labs founder Brian Pepin last year in a blog post.

Apple has focused a lot of time and money on expanding and updating the Watch's health and fitness tracking capabilities, with many more to come in future updates. Earlier this month the FDA also cleared watchOS's AFib History feature — which monitors irregular and extremely rapid heartbeat — and will be released in the upcoming watchOS 9 update. 

Shields Health Care hack may have exposed data for 2 million people

Shields Health Care Group, a Massachusetts-based company involved with imaging and health management services, has announced a major hack that could have exposed sensitive information for up to two million people. The company learned of the attack on March 28th, and after an investigation it found that a malicious actor had access to some of its systems between March 7th and 20th. 

Crucially, the hack included sensitive information like social security numbers, medical record information, patient IDs and insurance details. The company claims there isn't any evidence of identity theft from the incident, but there's still a chance customers could be compromised down the line. 

"Upon discovery, we took steps to secure our systems, including rebuilding certain systems, and conducted a thorough investigation to confirm the nature and scope of the activity and to determine who may be affected," the company said in a statement. "Additionally, while we have safeguards in place to protect data in our care, we continue to review and further enhance these protections as part of our ongoing commitment to data security."

Shields says it has contacted the FBI, as well as local and state regulators, about the incident. According to the AP, the FBI isn't commenting on the attack yet. Moving forward, Shields says it will contact customers once it learns who's affected.

watchOS 9 will include improved sleep tracking and medication reminders

Apple is at last promising better sleep tracking for Apple Watch as part of watchOS 9. The updated Sleep app will include a sleep stage function. It will be able to detect the REM, core and deep sleep stages and track those over time. 

You'll be able to view your sleep metrics alongside other data, such as heart rate and respiratory rate, in the Health app on your iPhone. Those who participate in the health research program will be able to submit their sleep stage data to Apple Heart and Movement Study researchers.

One of the more notable health features for watchOS 9 is that it will show how long a wearer is in a state of atrial fibrillation (AFib). It will inform you of the time of day or week that AFib is most active.

You'll receive weekly notifications to help you gain a better insight of your AFib frequency. The Health app will show a detailed history, along with information about lifestyle factors that may impact the condition, such as exercise, sleep and alcohol intake. You'll be able to download a PDF that includes your AFib history and lifestyle factors to share with your healthcare professionals.

The US Food and Drug Administration granted Apple approval just last week for the AFib history feature. It's only cleared for users in the US aged 22 and older who have been diagnosed with the condition.

In addition, Apple is introducing a Medications app for iPhone and Apple Watch to help users keep track of when to take their meds. You can set up custom schedules and reminders for each medication. Users in the US will be able to receive an alert if there are "potential critical interactions" with medications they add to the Health app.

Apple Medications app
Apple

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CVS won’t fill prescriptions for controlled substances from two telehealth companies

CVS will no longer fill prescriptions from telehealth companies Cerebral and Done Health for controlled substances. The pharmacy chain said that, following a review, it had unresolved concerns with both companies. The Wall Street Journal first reported the news.

"We are committed to making mental health services as accessible and convenient as possible. At the same time, it is important that medications are prescribed appropriately," CVS Health's executive director of corporate communications Mike DeAngelis told Engadget. 

"We recently conducted a review of certain telehealth companies that prescribe controlled substance medications. As a result of our being unable to resolve concerns we have with Cerebral and Done Health, effective May 26th, 2022, CVS Pharmacy will no longer accept prescriptions for controlled substances issued through these companies."

The startups have tens of thousands of patients between them, the Journal notes. They have prescribed stimulants such as Adderall for patients with attention-deficit hyperactivity disorder (ADHD). These stimulants are regulated and classed as schedule 2 controlled substances due to the risk of abuse.

Some other pharmacies, such as Walmart and Truepill, previously delayed or declined to fill prescriptions from the two startups. They reportedly had concerns that clinicians at Cerebral and Done were writing too many stimulant prescriptions.

It recently emerged that Cerebral is under investigation by the Department of Justice and the Drug Enforcement Administration. Following that news, the company put prescriptions for ADHD meds for new patients on hold. Cerebral said last week it would stop prescribing most controlled substances for all patients by October. Just two days after that, its board replaced CEO Kyle Robertson.

Along with ADHD, Cerebral says it treats depression, PTSD, anxiety disorders and serious mental illnesses through therapy, counseling and, in some cases, prescriptions. Done focuses on ADHD treatment. 

Before the onset of the COVID-19 pandemic, clinicians were banned from prescribing stimulants without an in-person visit with patients. Those federal rules were loosened in March 2020 for schedule 2 substances, which enabled Cerebral and Done to start offering prescriptions after virtual consultations.

Update 5/25 7:40PM ET: "We learned on the afternoon of Tuesday, May 24 that CVS will no longer fill Cerebral’s controlled substance prescriptions, effective Thursday, May 26. This decision does not affect Cerebral’s non-controlled substance prescriptions," Cerebral told Engadget via email. The company says is "doing everything possible to ensure these patients get access to medications that their health care providers have determined they need," as well as reaching out to impacted patients "to help ensure that their transition to another source of prescribed medications." Prior to CVS's decision, Cerebral says it had stopped new prescriptions for controlled substances due to the "impending expiration of waivers enacted during the [COVID-19] state of emergency."'

Update 5/26 10:30AM ET: "While we are disappointed with the decision of some pharmacies to prevent access to prescriptions generated on our platform, we will continue to provide them with clarity on Done and our commitment to high-quality psychiatric chronic care management," Done said in a statement to Engadget. 

"Done is currently assisting affected patients and providers with the transition of their pharmacy choice and we expect this situation will be quickly resolved, if provided the opportunity, so patients can access the medications they have been prescribed using evidence based medicine," it added. "Done hopes that companies with a mission to 'help people on their path to better health' and that are 'committed to patient safety and well-being' would value deeply rooted evidence based treatment for ADHD — a mental health condition, instead of placing additional barriers to care that millions struggle to receive on a daily basis."

Massive DNA study of human cancers offers new clues about their causes

A team of UK scientists has analyzed the complete genetic makeup of 12,000 tumors from NHS patients and discovered 58 new mutations that provide clues about their potential causes. The team, composed of scientists from Cambridge University Hospitals and the University of Cambridge, used data from the 100,000 Genomes Project. That's a British initiative to sequence the whole genomes of patients with cancers and rare diseases. 

Team leader Professor Serena Nik-Zainal said this is the largest study of its kind and that the vast amount of data her team worked with allowed them to detect patterns in the genetic alterations or "mutational signatures" found in the tumors. By comparing their results with other studies, they were able to confirm that 58 of the mutational signatures they found were previously unknown. Some of them are pretty common, while some are rare.

"The reason it is important to identify mutational signatures is because they are like fingerprints at a crime scene — they help to pinpoint cancer culprits," Nik-Zainal explained. Some signatures could show that past exposure to environmental causes such as smoking or UV light had triggered the cancer, while others could have treatment implications. They could, for instance, pinpoint genetic abnormalities that could be targeted by specific drugs. 

Professor Matt Brown, chief scientific officer of Genomics England said: "Mutational signatures are an example of using the full potential of [whole genome sequencing]. We hope to use the mutational clues seen in this study and apply them back into our patient population, with the ultimate aim of improving diagnosis and management of cancer patients."

In addition to conducting DNA analysis and publishing its results in Science, the team also developed an algorithm called FitMS that will give clinicians easy access to the new information they discovered. FitMS looks for both common and rare signatures in the results of a patient's whole genome sequencing test. Doctors can use the algorithm to find out if their patients exhibit any of the newly discovered mutations for a more accurate diagnosis and for personalized treatments.